APPLICATION
ANDA090441
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-11
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IMIPRAMINE HYDROCHLORIDEDiscontinued
IMIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
IMIPRAMINE HYDROCHLORIDEDiscontinued
IMIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
IMIPRAMINE HYDROCHLORIDEDiscontinued
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 9 · standardAP
2016-02-02Labeling · Supplement 7 · standardAP
2014-07-17Labeling · Supplement 6 · standardAP
2010-03-11OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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